NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032180154

Registered date:25/02/2019

A phase I/II clinical trial of radical radiotherapy using carbon-ion beams with standard adjuvant therapy for early breast cancer

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedBreast cancer
Date of first enrollment22/05/2018
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)Carbon-ion radiotherapy for breast tumor (no tumor resection). Adjuvant therapy is performed based on the guidelines for breast cancer.

Outcome(s)

Primary OutcomeAdverse reaction of normal tissue within 90 days after starting of the treatment.
Secondary Outcome1. Adverse reaction of normal tissue in late phase 2. Local effect (CR rate) 3. Local control rate with recommended dose 4. Breast cosmetic outcomes 5. Progression-free survival period 6. Overall survival period

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderFemale
Include criteria1. Pathologically proven invasive ductal carcinoma or ductal carcinoma in situ. 2. Tumor size <=20 mm on MRI. 3. No massive LVSI or EIC. 4. No lymphenode metastasis (>2 mm). Sentinel lymph node biopsy is performed prior this study. 5. No distant metastasis. 6. Performance status (ECOG) of 0 to 2. 7. 20 years old or older. 8. A life expectancy of at least 6 months. 9. Written informed consent.
Exclude criteria1. Severe complication (e.g. uncontroled lung disease, heart disease, infection, or psychiatric disease). 2. Previous treatment history including surgery, chemotherapy, endocrine therapy, molecular-targeted agents for breast cancer in same side. 3. Active other malignancy 4. The distanse between skin surface and tumor (including EIC) <=5 mm. 5. Previous radiation therapy for breast cancer in same side. 6. Eligible patients for "Breast cancer I" or "Breast cancer III". 7. Pregnancy, pregnancy potential. 8. Ptinents who are considered inappropriate by the attending physician due to medical, psychological or other factors.

Related Information

Contact

Public contact
Name Kana Kobayashi
Address 4-9-1 Anagawa Inage-ku, Chiba Chiba Japan 263-8555
Telephone +81-43-206-3306
E-mail kobayashi.kana@qst.go.jp
Affiliation QST Hospital, National Institutes for Quantum Science and Technology and Technology
Scientific contact
Name Kana Kobayashi
Address 4-9-1 Anagawa Inage-ku, Chiba Chiba Japan 263-8555
Telephone +81-43-206-3306
E-mail kobayashi.kana@qst.go.jp
Affiliation QST Hospital, National Institutes for Quantum Science and Technology